Press Release

Pooled safety and efficacy data for DEXENZA for the treatment of ocular pain and inflammation after ophthalmic surgery

Safety and efficacy data for DEXTENZA for the treatment of allergic conjunctivitis

Interim safety and efficacy data for OTX-TIC in subjects with glaucoma or ocular hypertension

New Preclinical Data for OTX-TIC (glaucoma), OTX-TKI (wet age-related macular degeneration), OTX-CSI (dry eye) and OTX-BPI (acute ocular pain)

BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 24, 2019-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced abstracts from its clinical and preclinical research will be highlighted at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, April 28 – May 2, in Vancouver B.C., and at the American Society of Cataract and Refractive Surgery (ASCRS) Symposium, May 3 -9, in San Diego, CA.

"We are very excited for the planned DEXTENZA^® launch. The data being presented, pooled from three Phase 3 clinical trials, demonstrate the benefit DEXTENZA provides in treating both ocular pain and inflammation after cataract surgery,” commented Michael Goldstein, M.D., MBA, Chief Medical Officer of Ocular Therapeutix. “We are also excited to be presenting additional data that demonstrate the breadth of our pipeline and the flexibility of our hydrogel platform by highlighting a number of product candidates we are developing for both front- and the back-of-the-eye diseases.”

Poster Presentations at ARVO Annual Meeting, Vancouver, B.C.:

• Pharmacokinetics of OTX-CSI, a Sustained Release Cyclosporine Intracanalicular Insert in Beagles. Vanslette A, Blizzard C, Haberman P, Tomaszewski J, Rosales C, Metzinger JL, Goldstein MH, Driscoll A
  Sunday, April 28, 2019; 8:00 AM – 9:45 AM
  West Exhibition Hall – B0424

• Efficacy & Tolerability of OTX-TKI, a Sustained Hydrogel Delivery System for a Tyrosine Kinase Inhibitor, in a VEGF Induced Retinal Leakage Model: 1 Year Results. Jarrett P, ElHayek R, Kahn E, Takach S, Metzinger JL, Goldstein MH
  Sunday, April 28, 2019; 1:00 PM – 2:45 PM
  West Exhibition Hall – A0249

• Pharmacodynamic Effect and Corneal Wound Healing of OTX-BPI, a Sustained Release Bupivacaine Intracanalicular Hydrogel Insert in Beagle Dogs. ElHayek R, Dexter J, Bello N, Kahn E, Manning S, Blizzard C, Driscoll A, Metzinger JL, Goldstein MH, Jarrett P
  Monday, April 29, 2019; 11:15 AM – 1:00 PM
  West Exhibition Hall – B0397

• Effect of OTX-TIC, a Sustained Release Travoprost Intracameral Implant on Central Corneal Thickness in Beagles. Driscoll A, Blizzard C, Desai A, Langh J, Buff N, Metzinger JL, Goldstein MH, Gelormini A
  Tuesday, April 30, 2019; 11:45 AM – 1:30 PM.
  West Exhibition Hall – A0115

• A Prospective, Multicenter, Open-Label First-in-Human Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (travoprost) Implant in Subjects with Primary Open-Angle Glaucoma or Ocular Hypertension: Preliminary Findings. Goldstein MH, Walters T, Goldberg D, Day D, Braun E, Metzinger JL
  Tuesday, April 30, 2019; 11:45 AM – 1:30 PM
  West Exhibition Hall – A0130

• Pharmacokinetics of OTX-TIC, a Sustained Release Travoprost Intracameral Implant in Rabbits. Blizzard C, Desai A, Langh J, Buff N, Metzinger JL, Goldstein MH, Gelormini A, Driscoll A
  Tuesday, April 30, 2019; 11:45 AM – 1:30 PM
  West Exhibition Hall – B0324

Abstracts and full session details can be found at www.arvo.org.

Paper Presentations at ASCRS in San Diego, CA:

• Evaluating the Safety, Tolerability and Efficacy of OTX-TIC, a Travoprost Intracameral Implant, in Subjects with Glaucoma. Walters T, Day D, Goldberg D, Braun E, Metzinger JL, Goldstein MH
  Sunday, May 5, 2019; 3:42 PM – 3:47 PM
  SDCC – Upper Level, Room 7A

• Management of Ocular Inflammation and Pain Following Cataract Surgery with Dexamethasone Insert (0.4 mg). Tyson S, Bafna S, Berdahl J, Walters T, Metzinger JL, Goldstein MH
  Monday, May 6, 2019; 8:02 AM – 8:07 AM
  SDCC – Upper Level, Room 1A

• Evaluating the Safety and Efficacy of DEXTENZA, a Dexamethasone Insert (0.4 mg) for the Treatment of Ocular Itching. McLaurin E, Torkildsen G, Sato M, Meier E, Gomes P, Metzinger JL, Goldstein MH
  Monday, May 6, 2019; 2:11 PM – 2:16 PM
  SDCC – Upper Level, Room 1B

Abstracts and full session details can be found at www.ascrs.org.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular pain following ophthalmic surgery. OTX-TP (intracanalicular travoprost insert) is an intracanalicular insert in Phase 3 clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension. The Company’s earlier stage assets include OTX-TIC, an extended-delivery intracameral travoprost implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These intravitreal implants include OTX-TKI, containing a tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure^® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA, ReSure Sealant or any of the Company’s product candidates, including the anticipated commercial launch of, and the receipt of reimbursement codes for, DEXTENZA; the development and regulatory status of the Company’s product candidates, such as the Company’s regulatory submissions for and the timing and conduct of, or implications of results from, clinical trials of DEXTENZA for the treatment of post-surgical ocular inflammation and the prospects for approvability of DEXTENZA for post-surgical ocular inflammation or any other indications, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the Company’s post-approval studies of ReSure Sealant and the Company’s ongoing communications with the U.S. Food and Drug Administration regarding the warning letter the Company received regarding ReSure Sealant; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any of the Company’s product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to obtain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company’s ongoing legal proceedings and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190424005271/en/

Source: Ocular Therapeutix, Inc.

Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
dnotman@ocutx.com

or

Westwicke, an ICR Company
Chris Brinzey
Managing Director
chris.brinzey@westwicke.com

Media
Ocular Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com